Parkinson Disease
Conditions
Keywords
Parkinson, Hippotherapy, Equine assisted therapy, Physiotherapy, Rehabilitation
Brief summary
The goal of this pilot randomized controlled trial is to investigate the effects of hippotherapy (horse assisted therapy) (intervention group) compared to usual care (control group) on mobility, gait, balance and perceived health-related quality of life in persons with Parkinson's disease. The main objectives of this study are: * The primary objective is to investigate the effects of hippotherapy on mobility of pwPD, walking speed and the ability to perform daily movements. * The secondary objective is to investigate the effects of hippotherapy on (a) balance, (b) self-perceived physical and mental health and (c) specific gait parameters. * Furthermore this study, aims to gather critical information that will inform about the design and implementation of a larger, more definitive randomized controlled trial. In addition to the three-week, multidisciplinary rehabilitation program the intervention group will receive hippotherapy (20 minutes) three times a week (7 sessions in total) and the control group will receive additional physiotherapy sessions (30 minutes) two times a week.
Interventions
OTHERHippotherapy
Hippotherapy is a form of physical therapy that utilizes the natural gait and movement of a horse to provide motor and sensory input. The hippotherapy sessions last 20 minutes each and aim at trunk rotation (in the transverse and frontal plane), rhythm and trunk stability.
OTHERPhysiotherapy
Physiotherapy sessions take 30 minutes and focus on core stability and exercises with large motor tasks
Sponsors
Klinik Valens
Schweizer Gruppe für Hippotherapie-K
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of Parkinson's diagnosis * Age \> 18 Years; * Hoehn \& Yahr stage ≤ 4; * Category 3 in the Functional Ambulation Categories * Climbing stairs is possible (with support).
Exclusion criteria
* Severe cognitive impairment, defined by a score below 26 on the Montreal Cognitive Assessment (MoCa) * Body weight \> 90kg; * Horse hair allergy; * Other acute and subacute cardiovascular, respiratory, musculoskeletal or neurological disorders that constitute a contraindication to hippotherapy (i.e. a recent fracture); * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional mobility. | From enrollment to the end of treatment at 3 weeks | Functional mobility will be measured with the expanded Timed Up and Go test. The eTUG is a modification of the traditional Timed Up and Go test, whereby the distance is increased from 6 to 10m. This has enabled a more accurate gait assessment in pwPD. Multiple time points are assessed: * The time the person takes to get from a sitting to standing position. * The time the person takes to walk the first two meters (gait initiation) * The time the person takes to walk the remaining (gait 1) * The time the person takes to turn (turning) * The time the person takes to (gait 2) * The time the person takes to slow down, turn and sit down again The more time someone takes to perform the test, the more the mobility is impaired. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance | From enrollment to the end of treatment at 3 weeks | Balance will be assessed with the Mini Balance Evaluation Systems Test (Mini-BESTest). The Mini-BESTest is shorter, more clinically applicable version of the original Balance Evaluation Systems Test (BESTest). This test focuses on subcomponents of balance control, such as anticipatory postural adjustments, postural responses, sensory orientation, and dynamic gait. It has proven to be effective in detecting balance impairments in persons with Parkinsons disease. The scale ranges from 0-28 points, with higher scores indicating better balance capacity. |
| Health related quality of life | From enrollment to the end of treatment at 3 weeks | Health related quality of life will be assessed with the Patient-Reported Outcomes Measurement Information System Global Health Short Form v1.2 (PROMIS-GH-10). The PROMIS-GH-10 is a ten-item questionnaire that assesses generic health related quality of life compared with normal values for the general population. It measures five domains: physical function, fatigue, pain, emotional distress, and social health on a five-point response matrix. Both physical and mental scores range from 0-20, with higher scores indicating a better perceived health related quality of life. |
| Walking capacity | From enrollment to the end of treatment at 3 weeks | Walking capacity will be tested using the 6 minutes walking test (6-MWT). With the 6-MWT, the total distance in meters covered within six minutes is assessed. The 6-MWT is performed on a 20-meter hallway, on which participants are asked to walk back and forth at maximal speed for the duration of six minutes without permission of rest. The instruction is standardized as "to walk at the fastest speed, and to cover as much distance as possible". Participants are allowed to use a walking aid, if necessary to ensure safe ambulation. The use of walking aids will be documented in the CRF, and participants are asked to use the same walking aid during the re-test at T1. During the tests, the research assistant blinded to group allocation is instructed, to not encourage the participant. The greater the distance walked during the test, the greater the walking endurance. |
Countries
Switzerland
Contacts
CONTACTJens Bansi, PhD
CONTACTIsa Slotboom, MSc
Outcome results
None listed